The ISET (Isolation by Size of Epithelial Tumor Cells) and the CellSearch Methods in Malignant Pleural Mesothelioma

Not Applicable

Completed

• Conditions: Pneumothorax; Tumor of the Thyroid; Pleural Neoplasms; Mesothelioma; Parathyroid Neoplasms; Benign Tumor of the Thyroid
• Interventions: Other: Blood sampling; Other: Control Group

• Registration Number: NCT01776385
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief Summary

Malignant pleural mesothelioma (MPM) has a growing incidence and in spite of early diagnostic, their outcome remains dismal. The evolution of MPM is often local with rare distant metastases. There is now a sizable body of evidence that metastases could develop from circulating tumor cells (CTC) spread in blood before or during surgery. Thus, sensitive and specific detection of CTC in blood is considered as a potentially relevant predictive biomarker for patients with carcinomas. In exchange, the prognostic value of CTC in MPM has not yet been evaluated.

Indeed, the main goal for preoperative detection of CTC is to identify patients with high risk of recurrence after surgery, in order to perform more adapted therapeutic strategy. Despite several studies reported about CTC detection, methodological aspects concerning sensitivity, specificity and reproducibility have prevented a clear appraisal of their clinical impact. Thus, the aim of our study is to evaluate the presence and the prognostic value of CTC in MPM by a double approach. In our setting, cytopathological analysis of circulating non hematological cells (CNHC), of epithelial origin, isolated according to their size (ISET, Isolation by Size of Epithelial Tumor cells) along with immunomagnetic selection, identification and enumeration of circulating epithelial cells in peripheral blood (CellSearch method) is considered a promising approach.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-03-23
• Study First Submitted QC: 2013-01-23
• Study First Posted: 2013-01-28
• Primary Completion: 2017-12
• Status Verified: 2018-02
• Study Completion: 2018-03
• Last Update Submitted: 2018-07-20
• Last Update Posted: 2018-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group patients	Blood sampling	Patients with Malignant Pleural Mesothelioma (all stages)
Control group	Control Group	Patients with pneumothorax or of benign tumor of the thyroid

Primary Outcome Measures

Name	Time	Method
Evaluation of presence / absence of CTC on the global survival	from Baseline in Systolic Blood Pressure at 6 months	Value forecasts of the presence / absence of CTC on the global survival estimated by the estimation and the test of meaning at 0 of the immediate relative risk (fate ratio) in a model at proportional risk.

Secondary Outcome Measures

Name	Time	Method
Value forecasts of the number of CTC on the global survival estimated by the risk	from Baseline in Systolic Blood Pressure at 6 months	Value forecasts of the number of CTC on the global survival estimated by the immediate relative risk Value forecasts of the presence / absence and the number of CTC on the survival without second offense(recurrence) or metastasis estimated by the immediate relative risk

Trial Locations

Locations (1)

CHU de Nice - LPCE- Hôpital de Pasteur - 30 ave de la voie Romaine; 🇫🇷 Nice, Alpes-Maritimes, France